{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2025-27560", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250703", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250508", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20250703", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240606", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "981463", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250703", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "K12240606", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(17)260630(10)K12240606", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/21/2025;08/20/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20251104", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20250703", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250611", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22396854", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250611", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "374046737", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT WAS LOOSE AND FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY." }, { "mdr_text_key": "374046738", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER ACCESSORY HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "384252498", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "384252499", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS OBTAINED: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE TIP COVER ACCESSORY FELL INSIDE THE PATIENT DURING INSTRUMENT REMOVAL, WHICH THE SURGEON ATTRIBUTES TO THE TIP COVER BEING TOO LOOSE. THE TIP COVER WAS RETRIEVED DURING THE SAME PROCEDURE. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS IN USE FOR 2.5 HOURS, AND NO ISSUES WITH ITS FUNCTIONALITY WERE NOTICED DURING THE SURGERY. THERE WAS NO COLLISION WITH OTHER INSTRUMENTS, AND THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED, WITH NO VISIBLE PART OF THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED, AND NO LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO INSTALLATION. A REDUCER WAS NOT USED, AND THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT AND ACCESSORY, AS THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. POST-EVENT INSPECTION REVEALED NO DAMAGE TO THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE MCS TIP COVER ACCESSORY HAS BEEN RETURNED TO ISI FOR EVALUATION, BUT THE MCS INSTRUMENT IS NOT AVAILABLE FOR RETURN." }, { "mdr_text_key": "380965547", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "380965548", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS RECEIVED AND FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS PLACED ON AND REMOVED FROM AN IN-HOUSE INSTRUMENT WITH NO ISSUES. THE INSTRUMENT ARTICULATED AS EXPECTED DURING MANUAL ARTICULATION AND WHEN DRIVEN ON THE IN-HOUSE SYSTEM. THE ACCESSORY WAS FULLY FUNCTIONAL AND FITTED CORRECTLY. NO PRODUCT ISSUE WAS IDENTIFIED. ADDITIONAL UNRELATED OBSERVATION NOT REPORTED BY SITE WAS THAT THE MCS TIP COVER ACCESSORY WAS FOUND TO HAVE GOUGES ON THE OUTER SURFACE OF THE TIP COVER. THE GOUGES WERE NOT AXIALLY ALIGNED. THERE WAS NO MATERIAL FOUND MISSING. THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/15/2025;09/11/2025" } ] }